摘要
[目的]系统评价“从毒论治”疗法治疗干燥综合征的疗效及安全性。[方法]检索中国知网(CNKI)、万方(Wanfang)、维普数据库(VIP)、PubMed等中英文数据库截至2024年12月的随机对照试验(RCTs),由两名研究者独立筛选文献、提取数据并评估偏倚风险,使用RevMan 5.4软件进行Meta分析,效应量以比值比(OR)和标准化均数差(SMD)表示。[结果]共纳入25项RCTs,涉及2274例患者。Meta分析显示,“从毒论治”组总体临床有效率显著高于对照组[OR=2.23,95%CI(1.77,2.82),P<0.05],且在改善眼干症状[泪膜破裂时间SMD=0.80,95%CI(0.37,1.23)]和口干症状[唾液流率SMD=1.51,95%CI(0.30,2.73)]方面疗效显著(P<0.05)。该疗法显著降低中医证候积分[SMD=-0.79,95%CI(-1.22,-0.37)]、炎症指标C反应蛋白[CRP,SMD=-0.45,95%CI(-0.79,-0.11)]及血沉[ESR,SMD=-0.29,95%CI(-0.45,-0.14)],并减少疾病活动度评分[ESSDAI,MD=-0.26,95%CI(-0.49,-0.02)]。基于“从毒论治”理论的干预措施可特异性降低IgG水平[亚组分析SMD=-0.36,95%CI(-0.71,-0.02),P=0.039]。安全性方面,“从毒论治”组不良反应发生率显著低于对照组[3.67%vs.11.16%,RR=0.33,95%CI(0.24,0.46)],主要表现为轻微胃肠道不适或皮疹。敏感性分析提示唾液流率、CRP等指标存在异质性,可能与干预方案多样性及疗程差异相关。[结论]“从毒论治”在提高干燥综合征患者的临床疗效、改善症状和抑制炎症反应方面优于常规治疗,且具有较高的安全性,为干燥综合征的临床治疗提供了新的选择。
[Objective]To systematically evaluate the efficacy and safety of“treatment based on toxin theory”for the treatment of Sjogren’s syndrome.[Methods]A comprehensive search was conducted in Chinese and English databases,including CNKI,WanFang,and PubMed,for randomized controlled trials(RCTs)up to December 2024.Two independent researchers screened the literature,extracted data,and assessed the risk of bias.RevMan 5.4 software was used to perform the Meta analysis,and the effect sizes were presented as Odds Ratios(OR)and Standardized Mean Differences(SMD).[Results]A total of 25 RCTs involving 2274 patients were included.The Meta-analysis showed that the“treatment based on toxin theory”group had a significantly higher overall clinical effective rate compared to the control group[OR=2.23,95%CI(1.77,2.82),P<0.05].This treatment also showed significant efficacy in improving dry eye symptoms[tear break-up time,SMD=0.80,95%CI(0.37,1.23)]and dry mouth symptoms[salivary flow rate,SMD=1.51,95%CI(0.30,2.73),P<0.05].The treatment significantly reduced Traditional Chinese Medicine(TCM)syndrome scores[SMD=-0.79,95%CI(-1.22,-0.37)],inflammatory markers including C-reactive protein[CRP,SMD=-0.45,95%CI(-0.79,-0.11)],and erythrocyte sedimentation rate[ESR,SMD=-0.29,95%CI(-0.45,-0.14)],and decreased disease activity scores[ESSDAI,MD=-0.26,95%CI:(-0.49,-0.02)].The intervention based on“Treatment based on toxin theory”specifically reduced IgG levels[subgroup analysis,SMD=-0.36,95%CI(-0.71,-0.02),P=0.039],but the overall improvement in immunoglobulin levels(IgA/IgG)did not reach statistical significance.Regarding safety,the“treatment based on toxin theory”group had a significantly lower incidence of adverse reactions compared to the control group[3.67%vs 11.16%,RR=0.33,95%CI(0.24,0.46)],with mild gastrointestinal discomfort or skin rashes being the primary adverse events.Sensitivity analysis indicated heterogeneity in some indicators,such as salivary flow rate and CRP,which may be related to the diversity of interventions and differences in treatment duration.[Conclusion]“Treatment based on toxin theory”shows superior efficacy compared to conventional treatments in improving clinical outcomes,alleviating symptoms,and suppressing inflammatory responses in patients with Sjogren’s syndrome.It also demonstrates high safety,providing a new option for clinical treatment of Sjogren’s syndrome.
作者
李建斌
刘维
LI Jianbin;LIU Wei(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《天津中医药》
2025年第9期1137-1148,共12页
Tianjin Journal of Traditional Chinese Medicine
基金
重大疑难疾病中西医临床协作项目-01直达资金-2024年中医药事业传承与发展(第二批)(20240905)
天津市南开区中医药传承创新发展示范试点项目(20240204011)
国家中医药管理局中西医结合与少数民族医药司政府采购服务项目(2023382)
天津市科技计划项目(22KPXMRC00180)
全国名老中医药专家传承工作室(975022-2024)
国家自然科学基金面上项目(82074377)
国家中医药管理中医药科技研究专项(GZY-KJS-2024-05)
中医药传承与创新“百千万”人才工程(岐黄工程)(中医药人民教育函〔2018〕12号)
国家中医药管理局中医药重点学科能力提升项目(2018Z DXK001)
中国民族医药学会科研项目(2020MZ319-350601)。
关键词
干燥综合征
燥痹
META分析
从毒论治
虚瘀毒论
Sjogren’s syndrome
dryness obstruction
Meta-analysis
treatment based on toxin theory
dficiency-stasis-toxin theory
